3DOSE 1ml Syringe
K-Number: K250733 · 2025-07-03
Decision Date2025-07-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
3DOSE 1ml Syringe is a medical device manufactured by Bimed Teknik Aletler Sanayi & Ticaret A.S.. It received FDA 510(k) clearance on 2025-07-03 under approval number K250733. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3DOSE 1ml Syringe?
3DOSE 1ml Syringe is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Bimed Teknik Aletler Sanayi & Ticaret A.S.. The 510(k) number is K250733.
When was 3DOSE 1ml Syringe approved by the FDA?
3DOSE 1ml Syringe received FDA 510(k) clearance on 2025-07-03, under approval number K250733.
What company makes 3DOSE 1ml Syringe?
3DOSE 1ml Syringe is manufactured by Bimed Teknik Aletler Sanayi & Ticaret A.S..
What is the FDA product code for 3DOSE 1ml Syringe?
The FDA product code for 3DOSE 1ml Syringe is FMF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.